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Start Over Formats Text ✖ Subjects Data Collection ✖ Publication Year 2019 ✖

1. Live case presentations during investigational device exemption (IDE) clinical trials: guidance for institutional review boards, industry, clinical investigators, and Food and Drug administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, July 11, 2019
Subject(s):: Clinical Trials as Topic
Device Approval
Data Collection
Ethics Committees, Research
Informed Consent
Single-Case Studies as Topic
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

2. Consideration of uncertainty in making benefit-risk determinations in medical device premarket approvals, de novo classifications, and humanitarian device exemptions: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, August 30, 2019
Subject(s):: Compassionate Use Trials -- standards
Cost-Benefit Analysis
Device Approval -- standards
Equipment and Supplies -- classification
Uncertainty
Data Collection
Reagent Kits, Diagnostic
Research Design
Sample Size
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

3. National review of opioid prescribing in Medicaid is not yet possible

Publication:: [Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, August 2019
Subject(s):: Analgesics, Opioid -- therapeutic use
Databases as Topic
Inappropriate Prescribing
Medicaid
Data Collection
State Government
Humans
United States